Alpha-1 Research, News & Events

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copy hese Web sites and resources dedicated to Alpha-1 research and clinical trials, news and events in the Alpha-1 community, and organizations serving the A

Stay up-to-date through these Web sites and resources dedicated to Alpha-1 research and clinical trials, news and events in the Alpha-1 community, and organizations serving the Alpha-1 community.

Alpha-1 research and trials

Alpha-1 disease management program improves patient health. A clinical study showed that a program designed to provide patient education enforced by regular telephone contacts, improves knowledge of Alpha-1, its treatment and patient health outcomes. The study found patients on therapy who were provided support compared to having no support had: more optimal long-term and short-term respiratory medication use, lower exacerbation rate (i.e., fewer breathing flare ups), fewer unscheduled physician/ER visits, and better overall patient satisfaction.1

Participate in Alpha-1 studies. Clinical trials are research studies performed on human subjects, and may include studies to evaluate the course of a disease, the cause of a disease, or the treatment of a disease. In the United States, the FDA decides whether the studies performed demonstrate sufficient beneficial effect on the disease and are sufficiently safe to warrant broad distribution of the drug to patients. There are also clinical trials going on in Alpha-1 that do not involve the testing of new drugs or therapies, many supported by the Alpha-1 Foundation. Find out more about participating in an Alpha-1 study.

Alpha-1 news and events

News about Alpha-1. Get the latest news and information through the Alpha-1 News and Community Currents newsletters, press releases and announcements, in addition to newsletters from support groups and the International Alpha-1 community. You can even submit newsworthy items or announcements. Learn more about Alpha-1 news.

Alpha-1 educational resources. Thousands of people with Alpha-1 and their families take advantage of resources like Alpha-1 Education Days, a regional program providing access to education for those who cannot travel long distances; the Annual National Education Conference, a weekend of education about health, nutrition, emotional support, and public policy provided by national experts and leaders in Alpha-1; materials published by the Alpha-1 Foundation on a variety of topics; the Alpha-1 News, a quarterly publication, bringing news and information to more than 10,000 members of the Alpha-1 Community. Find out how to access Alpha-1 educational resources.

Other Alpha-1 resources

AlphaNet is a not-for-profit health management company providing comprehensive services exclusively to the Alpha-1 community via care coordinators who are Alpha-1 patients themselves. AlphaNet provides personalized education and support to patients receiving PROLASTIN-C through Prolastin Direct® Patient Services. AlphaNet produces the Big Fat Reference Guide (Registration with AlphaNet required), a comprehensive guide to living with Alpha-1. To learn more, call 800-577-2638 or visit www.alphanet.org.

The Alpha-1 Foundation is the only national research organization solely dedicated to developing the means to cure and control Alpha-1 and to improve the quality of life for those with the disorder. Representatives of the Alpha-1 Foundation, medical, and scientific communities guide the strategic program direction and all activities of the Foundation. To learn more, call 877-2-CURE-A1 (877-228-7321) or visit www.alphaone.org.

IMPORTANT SAFETY INFORMATION

PROLASTIN®-C (alpha1-proteinase inhibitor [human]) is indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of alpha1-PI (alpha1-antitrypsin deficiency).

The effect of augmentation therapy with any alpha1-proteinase inhibitor (alpha1-PI), including PROLASTIN-C, on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. Clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with PROLASTIN-C are not available.

PROLASTIN-C is not indicated as therapy for lung disease in patients in whom severe alpha1-PI deficiency has not been established.

PROLASTIN-C is contraindicated in IgA-deficient patients with antibodies against IgA due to the risk of severe hypersensitivity and in patients with a history of anaphylaxis or other severe systemic reactions to alpha1-PI.

Hypersensitivity reactions, including anaphylaxis, may occur. Monitor vital signs and observe the patient carefully throughout the infusion. Should hypersensitivity symptoms be observed, promptly stop infusion and begin appropriate therapy. Have epinephrine and other appropriate therapy available for the treatment of any acute anaphylactic or anaphylactoid reaction.

PROLASTIN-C may contain trace amounts of IgA. Patients with known antibodies to IgA, which can be present in patients with selective or severe IgA deficiency, have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.

The most common drug-related adverse reaction observed at a rate of >5% in subjects receiving PROLASTIN-C was upper respiratory tract infection. The most serious adverse reaction observed during clinical trials with PROLASTIN-C was an abdominal and extremity rash in 1 subject.

Because PROLASTIN-C is made from human plasma, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. This also applies to unknown or emerging viruses and other pathogens.